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Oticon 193881

by Oticon A/S

Oticon 193881 is a Class II device made by Oticon A/S, listed in FDA GUDID since 20 Aug 2018 (UDI-DI 05707131343949), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05707131343949 UDI-DI Date20 Aug 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Oticon
Generic name
Audiometric/hearing device software
Model / reference
193881
Primary DI / UDI-DI
05707131343949
FDA product code
KLW, OSM
GMDN term
Audiometric/hearing device software
Device class
Class II
Regulation number
874.3400, 874.3305
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Audiometric/hearing device software

Similar devices

Other devices filed under FDA product code KLW (Masker, tinnitus).

Other devices from Oticon A/S

See all devices from Oticon A/S →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)